Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- 28-day Mortality
研究概览
简要总结
The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years old or older;
- •onset of septic shock within 6 h
排除标准
- •Systemic corticosteroid therapy within the last 3 months before septic shock;
- •high-dose steroid therapy;
- •immunosuppression;
- •refusal of the attending staff or patient family.
研究组 & 干预措施
Placebo
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
干预措施: saline (Drug)
hydrocortisone
Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
28-day Mortality
时间窗: 28 days
Death from any cause at 28 days after the onset of septic shock
次要结局
- All Cause Mortality(90 days)
研究者
Qing-quan Lv
Ms Lv
Northern Jiangsu People's Hospital